Ex Parte 6877530 et alDownload PDFBoard of Patent Appeals and InterferencesAug 24, 201295000335 (B.P.A.I. Aug. 24, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/000,335 01/11/2008 6877530 20010-013RX1 6157 76808 7590 08/24/2012 Leason Ellis LLP One Barker Avenue Fifth Floor White Plains, NY 10601-1526 EXAMINER WILLIAMS, CATHERINE SERKE ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 08/24/2012 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ INTELLIGENT HOSPITAL SYSTEMS LTD. Requester and Appellant v. FORHEALTH TECHNOLOGIES, INC. Patent Owner and Respondent ____________________ Appeal 2012-002609 Inter partes Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 Technology Center 3900 ____________________ Before, KARL D. EASTHOM, KEVIN F. TURNER, and JONI Y. CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 2 STATEMENT OF THE CASE This proceeding arose from a request for inter partes reexamination of U.S. Patent 6,877,530 B2 1 filed on January 11, 2008. Third-Party Requester, Intelligent Hospital Systems Ltd., appeals under 35 U.S.C. §§ 134(c) and 315(b) from the Right of Appeal Notice 2 indicating that amended claims 1-15 and new claims 21-40 in the reexamination of U.S. Patent 6,877,530 B2 are patentable over the cited prior art references. (App. Br. 8.) 3 The Patent Owner, ForHealth Technologies, Inc., filed a respondent brief, and is a party to this appeal under 35 U.S.C. § 315(a)(2). (Resp. Br.) 4 No litigation involving the ‘530 Patent has been identified. (App. Br. 4.) We heard oral arguments from both Requester and Patent Owner on April 10, 2012, a written transcript of which was entered into the electronic record on July 9, 2012. We have jurisdiction under 35 U.S.C. §§ 134(c) and 315(b). We reverse. Since our reversal of the Examiner’s decision not to adopt the Requester’s proposed rejections of claims 1-15 and 21-40 constitutes a new ground of rejection, our decision is not final for purposes of further judicial review. See 37 CFR § 41.77(b). 1 U.S. Patent 6,877,530 issued to Osborne et al. on Apr. 12, 2005, from Application 10/457,066, filed Jun. 5, 2003 ( “the ‘530 Patent”). 2 Right of Appeal Notice (“RAN”) dated on Mar. 30, 2010. Examiner’s Answer dated Sept. 29, 2010 (“Ans.”) incorporates by reference the RAN. 3 Appeal Brief filed on July 14, 2010 (“App. Br.”). 4 Patent Owner’s Respondent Brief filed August 10, 2010 (“Resp. Br.”). Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 3 The Invention The ‘530 Patent relates to a medication preparation system having a plurality of stations for filling syringes. (Col. 3:66 to 4:2; figs 1 and 3.) The system includes an automated device for controlling the movement of the syringe plunger to fill the syringe with a liquid medication. (Col. 3:66 to 4:29; figs 7 and 9.) Figure 3, reproduced below, illustrates an automatic syringe preparation system: Figure 3 illustrates an automated medication preparation system in which a plurality of syringes is indexed through the stations. (Col. 5:6-24.) The system includes a syringe storage station 120, a rotary apparatus 130 for advancing the fed syringes to various stations, and a station 155 that includes an automated device 700 for extending the plunger 50 of the syringe 10 a prescribed amount. (Col. 5:25-45; Col. 15:5-10.) The automated device 700 is connected to a programmable controller 470. (Col. 15:11-17.) The device 700 includes an automated puller 800 that engages the plunger 50 and extends it a calculated distance based on a number of parameters that are inputted into the controller 470. (Col. 15:18-27.) Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 4 Representative Claims on Appeal Claims 1 and 22 are representative of the subject matter on appeal: 1. (Once Amended) In an automated syringe preparation system in which a syringe undergoes processing at plural stations while seated in an indexed apparatus that moves the syringe from one station to another station, [An] an automated device for extending a plunger of [a] the syringe a defined distance within a syringe barrel based upon inputted syringe information, the device comprising: a housing having an adjustable plunger extension mechanism positioned to automatically receive and engage the seated syringe as it is advanced in the automated system; [an] the adjustable plunger extension mechanism [that includes] including a movable component that intimately engages the plunger so that movement of the component is translated into extension of the plunger of the seated syringe, the component including a controllable drive that moves the component the defined distance; a controller that receives the inputted syringe information and calculates the defined distance that the plunger is moved based on the inputted syringe information and instructs the controllable drive to move the plunger the defined distance; and a sensor device for monitoring whether a permitted length of travel of the movable component is such that the movable component has been driven to a maximum position, the sensor device being independent and stationary relative to the movable component. 22. (New) The automated device of claim 16 5 , wherein the controller includes a calibration table to determine the defined distance that the plunger is to be moved and wherein the input includes a customer code that indicates that special instructions have been supplied by a customer including the overfill value. (Amendment 2 and 8.) 6 5 Claim 16 has been determined by the Examiner to be unpatentable, and the rejection is not on appeal. (RAN 12-17; App. Br. 5). 6 Patent Owner’s Amendment filed on June 7, 2008 (“Amendment”). Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 5 Prior Art Relied Upon The Requester relies upon the following evidence: Hochman et al. U.S. Patent No. 6,200,289 B1, issued on Mar. 13, 2001. Ortiz et al. U.S. Patent No. 5,884,457, issued on Mar. 23, 1999. McConnell et al. U.S. Patent No. 5,363,885, issued on Nov. 15, 1994. Margrey et al. U.S. Patent No. 5,366,896, issued on Nov. 22, 1994. Zezulka et al. PCT International Application Publication WO 90/09776, published on 7 Sept. 1990. Hardie et al. U.S. Patent No. 5,479,969, issued on Jan. 2, 1996. Baldwin et al. U.S. Patent Application Publication 2002/0020459 A1, published on Feb. 21, 2002. Torchia et al. U.S. Patent No. 5,431,201, issued on Jul. 11, 1995. Fonss et al. U.S. Patent No. 5,004,962, issued on Apr. 2, 1991. Rao et al. U.S. Patent No. 5,948,360, issued on Sep.7, 1999. Ross U.S. Patent No. 3,965,945, issued on June 29, 1976. Hennessey et al. U.S. Patent No. 4,706,207, issued on Nov. 10, 1987. Kircher et al. U.S. Patent Application Publication 2002/0035412, published on Mar. 21, 2002. Cassel U.S. Patent No. 5,911,252, issued on Jun. 15, 1999. Carter U.S. Patent No. 5,288,285, issued on Feb. 22, 1994. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 6 Issues on Appeal Based on the issues raised by the Requester and Patent Owner in their arguments, we review the following issues in this appeal: 1. Whether one of ordinary skill in the art would have combined Hochman and Ortiz to conclude that claims 1-15, 21, and 25-40 were obvious? (App. Br. 9- 13; Resp. Br. 7-13.; Rebuttal Br. 5-9.) 2. Whether the combination of Hochman, Ross, Hennessey, and/or Kircher describes or suggests a calibration table and overfill instructions as recited in claims 22-24? (App. Br. 13-17; Resp. Br. 13-14.; Rebuttal Br. 9-12.) FINDINGS OF FACT The findings of fact that appear in this opinion, including those fact findings in the Analysis section, are supported by a preponderance of the evidence. Ortiz FF1. Ortiz describes an automated syringe preparation system for producing a plurality of prefilled syringes. (Col. 5:43-67; figs. 1 through 7G). In particular, the automated syringe preparation system 10 has a magazine drive motor 52 (fig. 1) and drive carriage 46 (fig. 7A) that move a feeding magazine 26 that holds a plurality of syringes 12 (col. 6:27-43; fig. 6) along the path 44 (col. 7:21-42) through a plurality of stations including the tip removing station 54, fluid filling station 66, and sealing station 84 in an indexed manner (col. 12:4-15). Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 7 FF2. Figure 7G of Ortiz, reproduced below, shows the automated system 10 includes a fluid filling station 66: Figure 7G illustrates an automated syringe preparation system. When the seated syringe 12 held by the feeding magazine 26 is positioned over the fluid filling station 66, a signal is sent by the controller 60 to raise the fluid filling station 66 upwardly into the second position to engage the connector 76 with the dispensing nozzle 16 of the syringe 12. Once the connector 76 and the dispensing nozzle 16 are engaged, the pump 70 is then automatically pump fluid from the fluid source 82 into the hollow barrel 14 of the syringe 12. (Col. 10:1-19; figs. 1, 3A-3C, and 7A-7G.) Hochman FF3. Hochman describes an automated drive mechanism that controls the flow rate and the amount of fluid that fills a syringe by controlling the movement of the syringe plunger. (Col. 4:45-46; col. 5:49-59; fig. 1.) Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 8 Baldwin FF4. Baldwin also describes an automated apparatus for syringe preparation that includes a plurality of stations. (¶0002 and figure 5.) Similar to Hochman’s automated drive mechanism, Baldwin has a filling station that controls the flow rate of the fluid by controlling the movement of the syringe plunger. Specifically, figures 11d-11e of Baldwin, reproduced below, illustrate the filling station 490 having a syringe flange retention track 492 and a plunger flange retention member 494: Figures 11d and 11e show syringe handling operations at the filling station. As shown by the above figures, Baldwin’s the plunger flange retention member 494 is selectively retractable relative to retention track 492 so that fluid may be drawn from liquid dispensing apparatus 420 to fill syringes S. (¶ 0103). Therefore, the distance that the plunger moves may be precisely controlled to achieve a preset filling volume. (¶ 0106). Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 9 PRINCIPLES OF LAW Obviousness “Section 103(a) forbids issuance of a patent when ‘the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.’” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) where in evidence, so- called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). ANALYSIS We begin our analysis by determining the scope and content of the prior art. Although the Patent Owner argues that the combination of Hochman and Ortiz does not teach all the elements of claim 1, the Patent Owner did not point out which element is not described by the collective teachings of the prior art references. (Resp. Br. 8.) As noted by the Examiner, Hochman describes most of the limitations recited in the claim. (RAN 4-5.) Further, Ortiz describes the other limitations as follows: (1) an automated syringe preparation system [10 in figs. 7A-7G; col. 5:45-48] in which a syringe [sterile delivery devices 12 in fig. 6; col. 5:55-57] undergoes processing at plural stations [e.g., tip removing station 52, fluid filling station 66, sealing station 84, and dispensing station 102 in in fig. 1; col. 12:4-15] while seated in an indexed apparatus [feeding magazine 26 in fig. 6-7G] that moves the syringe from one station to another station [the controller 60 actuates the Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 10 magazine drive motor 52 to move the feeding magazine 26 along the path 44 to pass each syringe 12 through the stations; col. 12:4-14; fig. 1 and fig. 7A]; and (2) a housing [a housing 48 in fig. 7A] having an adjustable plunger extension mechanism [fluid filling station 66 in figs. 3A-3C and 7D- 7G; col. 9:13-27] positioned to automatically receive and engage the seated syringe as it is advanced in the automated system [fluid filling station 66 in figs. 3A-3C; col. 10:1-16]. Given that, we agree with the Requester that the collective teachings of Hochman and Ortiz describe all of the limitations recited in claim 1. (App. Br. 10.) Issue 1: Claims 1-15, 21, and 25-40 Requester argues that the claimed invention would have been obvious in view of the combination of Hochman and Ortiz. (App. Br. 9-13.) Specifically, the Requester states that one skilled in the art would have been motivated to combine the teachings of Hochman and Ortiz “by the desirability of preparing multiple medication syringes in an organized and automated manner.” (App. Br. 12.) The Requester further states that Hochman and Ortiz are reasonably pertinent to the problem that the inventor of the ‘530 patent was trying to solve (i.e., “filing syringes with medication doses in an automated manner”). (App. Br. 10; Rebuttal Br. 6.) The Requester also argued that combining Hochman and Ortiz would predictably yield “a system that provides a series of indexed syringes for delivery to one or more patients.” (App. Br. 11-12; Rebuttal Br. 7-9.) The Examiner did not adopt the proposed rejection of claims 1-11, 21, and 36 as unpatentable over the combination of Hochman and Ortiz because, according to the Examiner, one of ordinary skill in the art would not have been motivated to combine Hochman with Ortiz. (RAN 5-7.) In particular, the Examiner finds that Hochman teaches an automated injection device for drug delivery to a single Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 11 patient whereas Ortiz teaches a system for automatically producing a plurality of liquid filled syringes. (RAN 6-7.) The Examiner further finds that incorporating the indexed apparatus of Ortiz into the Hochman’s device would destroy the Hochman device’s principle of operation (i.e., drug delivery) and there is no motivation to modify Hochman’s device to provide a plurality of liquid filled syringes. (RAN 6-7.) The Patent Owner agrees with the Examiner’s determination. (Resp. Br. 8- 13.) We, however, find the Requester’s arguments convincing. We note that “[i]t is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” In re Mouttet, No. 2011-1451, Slip op. at 15 (Fed. Cir. June 26, 2012). As such, we do not agree that Ortiz’s automated syringe preparation system must be bodily incorporated into Hochman’s automated drive mechanism. In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc); In re Keller 642 F.2d 413, 425 (Obviousness does not require that all of the features of the secondary reference be bodily incorporated into the primary reference.). Further, the assertion that Hochman’s principle of operation must be preserved is incorrect because it is based on the incorrect assumption that Hochman must remain as the “primary reference” and Ortiz must remain as the “secondary reference.” See In re Mouttet, Slip op. at 16 (“where the relevant factual inquiries underlying an obviousness determination are otherwise clear, characterization by the examiner of prior art as ‘primary’ and ‘secondary’ is merely a matter of presentation with no legal significance.”); see also In re Bush, 296 F.2d 491, 496 (CCPA 1961) (Rich, J.). Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 12 Rather, we find that one of ordinary skill in the art would have modified Ortiz’s automated indexed apparatus in view of Hochman, specifically implementing Hochman’s syringe plunger control system at the fluid filling station. Therefore, the Ortiz’s system would fill each syringe automatically by controlling the movement of the syringe plunger to regulate the flow rate and volume of the fluid based on the input information. Such modification would enhance the Ortiz system’s principle of operation, i.e., automatically filling a plurality of syringes and precisely controlling the flow rate of the liquid to achieve a preset volume. We also agree with Requester that modifying Ortiz’s automated syringe preparation apparatus in view of Hochman produces a predictable result. (App. Br. 11-12; Rebuttal Br. 7-9.) It was known in the art at the time of the invention that an automated syringe plunger control device (similar to Hochman’s system) may be operated in a syringe filling station of a mass production apparatus. See Baldwin, FF4. Further, we find that the prior art references, such as Ortiz and Hochman, demonstrate that the automated syringe preparation system recited in claim 1 can be formed using components known in the art and the components have been combined for their respective functions. For instance, Ortiz teaches an automated indexed apparatus 10 (including a feeding magazine 26 and fluid filling station 66) for carrying and moving a syringe 12 from one station to another and for receiving and engaging the syringe 12 automatically at the fluid filling station 66 (Ortiz, figs. 3A-3C and 6-7G). Hochman teaches a syringe plunger control system for controlling the movement of a syringe plunger to control the flow rate and volume of the fluid (Hochman, figs 1-4). See KSR, 550 U.S. at 417 (“[W]hen a patent ‘simply arranges old elements with each performing the same function it Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 13 had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.”) (citing Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976)). As to the Patent Owner’s assertion that Hochman is an injection device for drug delivery into a single patient, we do not find Hochman’s teachings so limited. A reference may be read for all that it teaches, including uses beyond its primary purpose. KSR, 550 U.S. at 416; In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979). Here, in the alternative embodiment, Hochman’s automated syringe plunger control system (that includes a drive mechanism 12 connected to a control unit 18) may be used for controlling the plunger 94 to draw fluid into the syringe. See e.g., Hochman col. 4:39-49; 5:49-54; 13:48-14:9; fig. 1. Thus, one of ordinary skill in the art would have recognized that Hochman’s automated syringe plunger control system could be used for filling a syringe with a fluid. Id. Such an artisan could use the Hochman system to control the movement of the syringe plunger to regulate the flow rate and to control the volume of the fluid being drawn into the syringe based on user input information (e.g., the type of syringe being used). Id. Patent Owner also argues that Ortiz is not directed to a device that operates a syringe plunger in an automated manner. (Resp. Br. 8-9.) In the Patent Owner’s view, “Ortiz fills the syringes through the dispensing nozzle and, as a result, the syringe piston plunger 18 moves passively in reaction to the filling operation without ever being engaged by anything.” Id. Patent Owner further alleges that “syringe of Hochman is part of a pump that cannot automatically receive and engage an already seated syringe.” Id. at 10-11. Specifically, Patent Owner contends that Hochman “discloses a purely manual method of loading the syringe onto the device that moves the plunger.” Id. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 14 We do not find the Patent Owner’s arguments compelling because nonobviousness cannot be established by attacking the references individually when the rejection is based upon a combination of prior art disclosures. See In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, in the combination of Hochman and Ortiz, the syringe would be seated in Ortiz’s feeding magazine 26 and moved from one station to another by Ortiz’s drive motor 52 and drive carriage 46 (figs. 6-7G), and Hochman’s drive mechanism 12 would be operating and engaging the syringe plunger at Ortiz’s fluid filling station (similar to Baldwin’s second embodiment discussed at ¶¶ 0103-0106 and illustrated in figs. 11a-11h, and the Requester’s second figure on page 8 of the Rebuttal Brief). The Requester proffers several reasons as to why one ordinary skill in the art would have been led to combine Hochman’s automated mechanism device with Ortiz’s automated syringe preparation apparatus. (App. Br. 12.) The Requester further articulates the following advantage (id.): The collection of syringe specific information and determination of the defined distance of travel of the syringe plunger based on the inputted syringe information, as described by Hochman, could benefit the functionality of the fluid filling station of Ortiz, for example, by providing an extra level of quality assurance, especially in the circumstance of filling various sizes of syringes within a batch operation. Given that and the advantages of automating the manual process of filling syringes stated in the prior art (e.g., Ortiz col. 1:11-17 and Baldwin ¶ 0003), we find there are sufficient reasons based on rational underpinnings to explain why one of ordinary skill in the art would have been led to modify Ortiz’s automated indexed syringe preparation apparatus in view of Hochman. For the foregoing reasons, one of ordinary skill in the art would have found the subject matter in claim 1 obvious. The Requester and Patent Owner did not Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 15 provide separate arguments for claims 2-11, 21, and 36. Accordingly, we reverse the Examiner’s refusal to adopt the proposed rejection of claims 1-11, 21, and 36 as unpatentable over the combination of Hochman and Ortiz. As to claims 12-15, the Examiner did not adopt the proposed rejection of claims 12-15 for the same reasons given with respect to claim 1. (RAN 8-10.) The Examiner further states that (RAN 10): However, neither Hochman nor Fonss teach [sic] “an automated syringe preparation system in which a syringe undergoes processing at plural stations while seated in an indexed apparatus that moves the syringe from one station to another station” and where the adjustable plunger extension mechanism is positioned to automatically receive and engage the seated syringe as it is advanced in the automated system. These limitations are recited in claim 1. The Requester proposed that claim 12 should be rejected for the same reasons given with respect to claim 1. 7 Claims 13- 15 depend from claim 12. Further, the Requester and Patent Owner did not provide separate arguments for claims 12-15. (App. Br. 9-13; Resp. Br. 13.) As discussed previously, we find that Ortiz teaches these limitations, and one of ordinary skill in the art would have combined Ortiz and Hochman and found the subject matter in claim 1 obvious. We therefore reverse the Examiner’s refusal to adopt: (1) the proposed rejection of claim 12 as unpatentable over the combination of Hochman and Ortiz in view of Fonss; and (2) the proposed rejection of claims 13-15 as unpatentable over the combination of Hochman and Ortiz in view of Fonss and Rao. 7 Third Party Comments on Patent Owner Response filed on July 7, 2008 (“3PR Comments”), page 6. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 16 As to claims 25-27 which depend from claim 1, the Examiner did not adopt the proposed rejection for the same reasons given as to claim 1. (RAN 19.) Specifically, the Examiner states that the proposed rejection of claims 25-27 over Hochman in view of Cassel does not solve the deficiencies of amended claim 1. Id. The Requester and Patent Owner provide no separate argument for claims 25- 27. (App. Br. 9-13; Resp. Br. 13.) As discussed previously, one or ordinary skill in the art would have found the subject matter of claim 1 obvious in view of the combination of Hochman and Ortiz. We therefore reverse the Examiner’s refusal to adopt the proposed rejection of claim 25-27 as unpatentable over the combination of Hochman and Ortiz in view of Cassel. As to claims 28-35, and 37-40, the Examiner did not adopt the proposed rejections for the same reasons given with respect to claim 1. (RAN 20-21.) The Requester and Patent Owner do not provide separate arguments for these claims. (App. Br. 9-13; Resp. Br. 13.) Claim 28 depends from independent claim 16, and claims 29 and 38-40 depend from claim 16 through claim 28. Claim 30 depends from independent claim 19, and claims 31-34 depend from claim 19 through claim 30. Claim 35 depends from claim 1, and claim 37 depends from claim 1 through claim 36. The Examiner rejects independent claims 16 and 19 as being unpatentable over Hochman in view of Ross. (RAN 12-16 and 22-23.) These rejections, however, are not being appealed by the Patent Owner. Claims 28 and 30 further recite “wherein the automated device for extending the plunger is part of an automated syringe preparation system in which the syringe undergoes processing at plural stations…” These limitations also appear in Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 17 claim 1. As discussed previously, we find that Ortiz teaches these limitations and one of ordinary skill in the art would have combined Hochman and Ortiz, and found the subject matter in claim 1 obvious. Accordingly, we reverse the Examiner’s refusal to adopt: (1) the proposed rejections of claims 28-34 and 38-40 as unpatentable over the combination of Hochman and Ortiz in view of Ross, and in further view of McConnell, Margrey, Zezulka, Hardie, Baldwin, and/or Torchia; and (2) the proposed rejection of claims 35 and 37 as unpatentable over the combination of Hochman and Ortiz in view of Baldwin. Issue 2: Claims 22-24 The Examiner refuses to adopt the proposed rejection of claims 22-24 as unpatentable over Hochman in the combination of Ross, Hennessey or Kircher because the references do not describe a calibration table as recited in claim 22. (RAN 17.) In particular, the Examiner does not find Hochman’s data bank to be a calibration table as recited in claim 22. (RAN 17.) The Requester however argues that Hochman teaches substantially the same approach as the ‘530 patent, using information in a table that contains physical characteristics of the syringes and user inputs to determine the distance the syringe plunger travels. (App. Br. 13.) We find the Requester’s argument convincing. We first review the Specification of the ‘530 Patent to determine the meaning of the term “a calibration table.” The ‘530 Patent provides that “[t]he software of the programmable control is written so that it contains calibration tables for various syringe types.” (Col. 21:21-23.) The ‘530 Patent also provides the following (col. 20:60-col. 21:8): Unlike many of the conventional automated systems, the present system provides many more options for the user and also permits the Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 18 distance that the plunger is extended to be readily changed. More specifically, the user only has to input the necessary information, such as the syringe type, and because the controller is a programmable unit, it includes databases of information. The controller accesses these databases and is able to retrieve the syringe characteristics based on the limited information that the user provided. For example, the barrel diameter and the volume specifics about the barrel are determined and then based on the inputted desired (target) volume of the prescribed dose, the controller computes the distance that the plunger needs to be extended in order to form a dosage receiving space of sufficient and optimal dimension. Given that, we recognize that the distance that the plunger needs to be moved is calculated by the controller, rather than the calibration table. The controller calculates the distance based on the inputted desired volume of the medication and the syringe characteristics (e.g., barrel diameter) retrieved from the databases, given the user input information (e.g., the syringe type). The disclosure of the ‘530 Patent implies that the calibration tables are the databases used to calculate the distance that the plunger needs to be moved. Therefore, one of ordinary skill in the art would have recognized that a calibration table contains the syringe type and the syringe characteristics for that particular syringe type. Similar to the calibration table of the ‘530 Patent, Hochman’s data bank contains the syringe types and the syringe characteristics. Specifically, Hochman describes a memory 160 that is used to store programming and data for the master microprocessor 152 (which is part of the controller 150). (Col. 8:17-18 and 38- 44.) The memory 160 stores data banks that contain the following information: (a) syringes; (b) tubing; (c) needles; (d) fluids; (e) governor parameters; and (f) profiles consisting of a plurality of parameters for a particular procedure to be performed. Id. Once a syringe is selected, its physical characteristics such as Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 19 length, nominal volume, stroke length, syringe force are retrieved from the data bank and displayed as shown in Fig. 12A. (Col. 9:38-43.) The master microprocessor 152 may be programmed to perform the calculations necessary to generate the profiles. (Col. 10:32-37.) For filling a syringe, the system controls the motor to run for a predetermined time causing the plunger 94 to move for the predetermined distance. (Col. 13:58-col. 14:9.) Given those teachings, one of ordinary skill in the art would have recognized that Hochman’s controller uses the data bank to calculate the distance that the plunger needs to be moved. Therefore, we conclude that Hochman describes the limitation “wherein the controller includes a calibration table to determine the defined distance that the plunger is to be moved” as recited in claim 22. The Patent Owner additionally argues that Hochman fails to describe the following element in claim 22: “wherein the input includes a customer code that indicates that special instructions have been supplied by a customer including the overfill value.” (Resp. Br. 14.) According to the Patent Owner, Hochman fails to describe such a feature because the syringe used in Hochman is prefilled when introduced into the Hochman device. Id. We are not persuaded by Patent Owner’s arguments. First, the Patent Owner’s argument relies on the preferred embodiment of Hochman for drug delivery into a single patient, and fails to recognize other teachings in Hochman. As previously discussed, Hochman’s alternative embodiment describes an automated syringe plunger control system that could be operated to drawn fluid into the syringe electronically based on user input information. Therefore, the syringe used in Hochman’s alternative embodiment is not prefilled. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 20 Second, as the Examiner points out, Ross specifically teaches the concept of syringe overfill in order to assure ejection of an entrapped air from the syringe during filling the syringe. (RAN 14, citing to Ross col. 4:12-41.) The Examiner also articulates the reason as to why one of ordinary skill in the art would have combined the teachings of Hochman and Ross is to assure the consistent filling of syringes with absolute correct dosages of medicament as provided by Ross (col. 5:4-7). (RAN 14.) Thus, one of ordinary skill in the art at the time of invention would have been led to include an additional variable overfill value, depending on the type of syringe and fluid being filled, in Hochman’s control system, as taught by Ross, in order to assure ejection of any entrapped air from the syringe during filling of the syringe. (RAN 14; see also Ross col. 5:4-7.) We further find that it is well known in the art that an automated system can be programmed to slightly overfill the syringe (see e.g., Hennessy, col. 12:31-33), and an automated medication preparation apparatus may be adjusted for a user defined overfill volume by increasing the volume of the medication so that the correct amount of medication will in fact be delivered to the patient (Kircher, ¶ 0115). Given the collective teachings of the prior art references, one of ordinary skill in the art would have been led to program Hochman’s automated plunger control system, specifically the controller, to slightly overfill the syringe based on a user defined overfill volume so that the correct amount of medication will be delivered to the patient. For the foregoing reasons, we reverse the Examiner’s refusal to adopt the proposed rejection of claims 22-24 as unpatentable over Hochman in view of Ross, Hennessey or Kircher. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 21 CONCLUSION We reverse the Examiner’s refusal to adopt the following proposed rejections: (1) The proposed rejection of claims 1-11, 21, and 36 as unpatentable over the combination of Hochman and Ortiz; (2) The proposed rejection of claim 12 as unpatentable over the combination of Hochman and Ortiz in view of Fonss; (3) The proposed rejection of claims 13-15 as unpatentable over the combination of Hochman and Ortiz in view of Fonss and Rao; (4) The proposed rejection of claim 25-27 as unpatentable over the combination of Hochman and Ortiz in view of Cassel; (5) The proposed rejections of claims 28-34 and 38-40 as unpatentable over the combination of Hochman and Ortiz in view of Ross, and in further view of McConnell, Margrey, Zezulka, Hardie, Baldwin, and/or Torchia; (6) The proposed rejection of claims 35 and 37 as unpatentable over the combination of Hochman and Oritz in view of Baldwin; and (7) The proposed rejection of claims 22-24 as unpatentable over Hochman in view of Ross, Hennessey or Kircher. SUMMARY We reverse the Examiner’s decision not to reject claims 1-15 and 21-40. Under 37 C.F.R. § 41.77(b), the Board’s reversal of the Examiner’s decision not to reject the claims constitutes a new ground of rejection. Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 22 This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.77(b) which provides that “[a]ny decision which includes a new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Correspondingly, no portion of the decision is final for purposes of judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if appropriate, however, the Board may elect to defer issuing any decision on such request for rehearing until such time that a final decision on appeal has been issued by the Board. 37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE MONTH FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. … REVERSE 37 C.F.R. § 41.77(b) lb Appeal 2012-002609 Reexamination Control No. 95/000,335 U.S. Patent 6,877,530 B2 23 PATENT OWNER: LEASON ELLIS LLP ONE BARKER AVENUE FIFTH FLOOR WHITE PLAINS, NY 10601-1526 THIRD-PARTY REQUESTER: FISH & RICHARDSON P.C. 3200 RBC PLAZA 60 SOUTH SIXTH STREET MINNEAPOLIS, MINNESOTA 55402 Copy with citationCopy as parenthetical citation